Embo Registry; National Registry for Artery Embolization

Multicenter National Registry for Artery Embolization (Embo Registry) for the Treatment of Osteoarthritis and Areas of Localized Pain to Assess Treatment of Artery Embolization to Determine if Subjects Have Decrease Pain, Decreased Use of Narcotics and NSAIDs, and Quality of Life Improvement Post Procedure.

Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Osteoarthritis, Knee; Pain, Chronic; Osteoarthritis Thumb; Tenosynovitis; Osteoarthritis Shoulder; Tendonitis Elbow; Tendonitis;Achilles; Tendonitis Shoulder
• Intervention / Treatment: Procedure: Artery Embolization

Detailed Description

Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes. The embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. Tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. This reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment. For the study to determine efficacy and overall improvement of patients post procedure by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale (VAS) scores, Western Ontario and McMaster Universities Index (WOMAC), EQ-5D-5L Quality of Life Questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Amer Iqbal; Phone Number: 919-897-5999; Email: amer@vascularsolutions.org
• Study Contact Backup: Name: Meaghan Thomas, CCRP; Phone Number: 9198975999; Email: meaghan@vascularsolutions.org

Study Locations

• United States
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Vascular Solutions of North Carolina
      • Principal Investigator: Siddhartha Rao, MD
      • Contact: Meaghan Thomas, CCRP; Phone Number: 9198975999; Email: meaghan@vascularsolutions.org
      • Contact: Amer Iqbal; Phone Number: 919-897-5999; Email: amer@vascularsolutions.orh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic and localized pain from diagnoses such as osteoarthritis, tendonitis, tenosynovitis, or injury who underwent Artery Embolization for the treatment of their symptoms/pain.

Description

Inclusion Criteria:

• > 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group; For the study to determine efficacy and overall improvement of patients post artery embolization by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale (VAS) scores, Western Ontario and McMaster Universities Index (WOMAC), EQ-5D-5L Quality of Life Questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively.

Procedure: Artery Embolization; Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes. The embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. Tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. This reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment.; Other Names: GAE; Genicular Artery Embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Clinical success at 3 months, defined as improvement in Western Ontario and McMaster University (WOMAC) Pain Subscale from pre-operative/baseline WOMAC scores.	3 months
Primary Outcome	Clinical success at 3 months, defined as improvement of Visual Analog Scale (VAS) Scores from pre-operative/baseline scores.	3 months
Primary Outcome	Comparative assessment at 3 months of decreased use of medication prescribed at baseline to 3 months post operatively.	3 months
Primary Outcome	Clinical success at 3 months, as defined by improvement in the quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	Number of patients achieving clinical success at 1,3, 6, and 12-months post procedure.	12 months
Secondary Outcome	Decrease in Western Ontario and McMaster University (WOMAC) index compared to baseline, 1, 3, 6, and 12 months.	12 months
Secondary Outcome	Pain score assessed using Visual Analog Scale (VAS) Score from baseline, 1, 3, 6, and 12 months.	12 months
Secondary Outcome	Number of subjects who had pain reduction >50% in the mean VAS pain scale at 1, 3, 6 and 12 months in comparison with baseline/preprocedural assessments.	12 months
Secondary Outcome	Change in the use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's) compared to baseline through 1, 3, 6, and 12 months.	12 months
Secondary Outcome	Change in quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline through 1, 3, 6, and 12 months.	12 months
Secondary Outcome	Number of patients with confirmed cases of osteoarthritis with a Kellgren and Lawerence Grade Level 2-3 (confirmed by X-Ray) improved symptoms compared to baseline through to 1, 3, 6 and 12-months post procedure.	12 months

Collaborators and Investigators

• Sponsor: Vascular Solutions of North Carolina
• Investigators: Principal Investigator: Siddhartha Rao, MD, Vascular Solutions of North Carolina; Study Director: Amer Iqbal, Vascular Solutions of North Carolina; Study Chair: Meaghan Thomas, CCRP, Vascular Solutions of North Carolina

Publications and helpful links

Helpful Links

• contact study

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2029

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Estimated): June 27, 2024

Study Record Updates

• Last Update Posted (Estimated): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Pain; Tendonitis; Tenosynovitis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Tendon Injuries; Osteoarthritis; Osteoarthritis, Knee; Chronic Pain; Tendinopathy; Tenosynovitis
• Other Study ID Numbers: 20241915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Dissemination of data will be through publications in peer-reviewed scientific journals, national and international meeting, on-line presentations, and providing de-identified data to participating site investigators and by providing analysis results upon request from site investigators.
• IPD Sharing Time Frame: 12 months
• IPD Sharing Access Criteria: Must contact sponsor for approval or participate in study research.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No